NCT06127784 Survivorship After HNC: A Randomized Controlled Trial Evaluating Patient Care and Adherence to Follow-up
| NCT ID | NCT06127784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western University, Canada |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2025-05-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Treatment summary and survivorship care plans (TSSPs) are poorly studied in Head and Neck Cancer (HNC) patients, and given the high frequency of unmet needs, this patient population has potentially the most to benefit from the implementation of TSSPs. A preliminary feasibility randomized control trial (RCT) at London Regional Cancer Program (LRCP) of 18 patients with HNC evaluating the implementation of TSSPs, found that patients assigned to the intervention group had a 15% higher rate of physician implementation of survivorship care needs compared to the usual care group (40% versus 25%, respectively). Results of the pilot study indicated that successful execution of TSSPs and counselling sessions for HNC patients is feasible. In follow up to the initial feasibility trial, the present investigation seeks to execute a large-scale randomized controlled trial. Three hundred and four patients who were treated at the London Regional Cancer Program (LRCP) for HNC will be randomly assigned to either usual care or a survivorship care plan (TSSP) intervention (90 patients in each arm). The intervention will consist of the delivery of a TSSP and a motivational interviewing counseling session with a clinical nurse specialist tailored to the needs of this vulnerable cancer population. The primary objective of the study is to evaluate the delivery of a TSSP during a one-on-one motivational interviewing counselling session with HNC survivors to determine whether the intervention results in improved implementation of recommendations for HNC survivors compared to usual care. Secondary study objectives will evaluate quality of life and satisfaction with care at 12 months post-intervention between the usual care and intervention group. Primary care providers of patients assigned to the intervention group will also be surveyed on the utility of the TSSP.
Eligibility Criteria
Patient Participants Inclusion Criteria: * Age 18 years or older * Willing to provide informed consent * Diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx) * Last definitive treatment (surgery, chemotherapy, radiotherapy) between 3 and 6 months prior to enrollment * English speaking, reading and writing Exclusion Criteria: * Second concurrent non-cutaneous malignancy * Metastatic disease * Clinically apparent cognitive impairment * Suspected residual disease after treatment completion
Contact & Investigator
Danielle MacNeil, MD, FRCSC
PRINCIPAL INVESTIGATOR
Department of Otolaryngology-Head & Neck Surgery, Western University Canada
Frequently Asked Questions
Who can join the NCT06127784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06127784 currently recruiting?
Yes, NCT06127784 is actively recruiting participants. Contact the research team at Agnieszka.Dzioba@lhsc.on.ca for enrollment information.
Where is the NCT06127784 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06127784 clinical trial?
NCT06127784 is sponsored by Western University, Canada. The principal investigator is Danielle MacNeil, MD, FRCSC at Department of Otolaryngology-Head & Neck Surgery, Western University Canada. The trial plans to enroll 176 participants.
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